搜索
FDA临床试验常见词汇中译文对照Aactionletter决定通知activecomparator活性药物对照组activecontrol=AC阳性对照，活性对照activeingredient有效成分ActiveSubstanceMasterFile(ASMF)欧洲药物主文件acutemyocardialinfarction急性心肌梗死acutetibialfractures急性胫骨骨折adalimumab(Humira)阿达木单抗adaptivedesign自适应设计adaptiverandomization自适应随机ADE=adversedrugevent药物不良事件AdenoviralVectors腺病毒载体adequateandwell-controlledstudies充分严格的对照研究ADHD=Attention-deficithyperactivitydisorder注意力缺陷多动障碍;注意力不足过动症;多动症adhesionbarrierproduct防黏著产品adjuvant助剂;佐剂auxiliary;adjuvanttherapy佐药疗法，辅助疗法ADL=activitiesofdailyliving日常生活活动能力ADME=absorption,distribution,metabolism,andexcretion(药物)吸收、分配、代谢和排除ADR=adversedrugreaction药物不良反应adrenalcortex肾上腺皮质adrenalcorticalhormone肾上腺皮质激素adrenalgland肾上腺adrenaline肾上腺素adulterateddevices掺假器械adversedrugreaction=ADR药物不良反应adverseeffect副作用adverseevent=AE不良事件adversemedicalevents不良医学事件adversereaction(adverseevent)药物不良反应advisory提醒advocacyandsupportgroups倡导和支持团体AE=adverseevent不良事件AERS=AdverseEventReportingSystem不良事件报告系统BBIMOBioresearchMonitoringProgram生物研究监测bioavailability(F)生物利用度biochemicaldrugs生化药品biocides生物杀灭剂;杀生物剂biocompatibility生物相容性biodegradable生物分解bio-engineered,transgenicfood转基因食物bioequivalence;bioequivalent生物等效应biofilm细菌薄膜,生物膜biologic生物制品biologicalresponsemodifiersBRM生物应答调节剂biologicaltherapeuticagents生物治疗药剂biomarker生物标志物biometrics生物统计;生物识别技术bionstimulator生物体刺激器bionicknee仿生膝关节biopharma:biopharmaceuticalproducts生物药物产品bipolar双相燥郁症birthdefect出生缺陷,新生儿缺陷,先天缺陷BLA=biologiclicenseapplication生物制品许可申请blankcontrol空白对照blenduniformityanalysis混合均匀度分析blind盲法blindcodes编制盲底blindreview盲态审核blindingmethod盲法blinding/masking盲法，设盲blisterpackaging泡罩包装;水泡眼block分段;层blocksize每段的长度blockedrandomization区组随机Ccasehistory病历caserecordform=CRF病例报告表/病例记录表casereportform病例报告表cashcurve现金曲线cashtrap现金陷阱;现金套牢categoricalvariable分类变量CLIAClinicalLaboratoryImprovementAmendments临床实验室改进修订案clinical(human)data临床数据clinicalendpoint临床终点clinicalequivalence临床等效应clinicalhold临床试验暂停通知clinicalinvestigator临床研究者ClinicalPharmacists临床药师ClinicalResearchCoordinator=CRC临床研究协调者clinicalstudy临床研究ClinicalStudyApplication=CSA临床研究申请clinicalstudyreport临床试验的总结报告clinicaltrial临床试验clinicaltrialapplication=CTA临床试验申请clinicaltrialexemption=CTX临床试验免责clinicaltrialprotocol=CTP临床试验方案ClinicalTrialReport=CTR临床试验报告clinicallysignificantresults有临床意义cohort队列cohortstudies队列研究co-investigator=CI合作研究者comparison对照CompassionateUse体恤使用competitivelabeling优越标签ComplementaryAndAlternativeTherapy补充性和非传统治疗Completeresponse完全有效compliance遵守；对遵守法规情况的监管compositevariable复合变量CompressionTest压缩试验computer-assistedtrialdesign=CATD计算机辅助试验设计ConMeds=concomitantmedications联合用药confidenceinterval可信区间confidencelevel置信水平ConfidentialityRegardingTrialParticipants为试验参与者保密control对照controlgroup对照组controlledclinicaltrials临床对照实验ControlledTrials对照试验CriticalPath关键路径CRM=continualreassessmentmethod连续重新评估方法crossoverdesign交叉设计cross-overstudy交叉研究crossovertherapy交叉治疗CRF=casereportform病例报告表dosageform剂型dosageregimen给药方案dose-rangingstudy剂量范围研究dose-reactionrelation剂量－反应关系dose-relatedadversereactions剂量相关的不良反应doubleblinding双盲doubledummy双模拟doubledummy双模拟doubledummytechnique双盲双模拟技术double-blindstudy双盲研究Double-MaskedStudy双盲研究DRGs=DiagnosisRelatedGroupSystem疾病诊断相关分组dropout脱落droptest落震试验;跌落试验drugelutingcoronarystents药物洗脱支架drugproduct药物产品drugsubstance原料药drug-druginteraction56药物-药物相互作用drug-foodinteraction药物-食物的相互作用EEPS=ElectronicEntryProcessingSystem电子录入处理系统effectiveness疗效efficacy有效性测定efficacy(Ofadrugortreatment)药效；药品疗效EEMEA=EuropeanMedicalEvaluationAgency;EuropeanAgencyfortheEvaluationofMedicinalProducts;EuropeanMedicinesAgency药物评价机构;欧洲医药品管理局emergencyenvelope应急信件EmpiricBayesianMultipleGamma-PoissonShrinker经验性贝氏法（伽玛泊松分布缩检法）empirical经验性endpoint终点endpointcriteria终点指标factorialdesign析因设计factorialtrial析因试验failure无效，失败FairPackagingandLabelingAct(1966)公平包装和标签法FalseClaimsAct防制不实请求法falsetherapeuticclaims错误的疗效声明fullanalysisset全分析集fullfactorialdesign全因子试验法Iinclusioncriteria入选标准inclusion/exclusioncriteria入选/排除标准incrementalexposure食品中递增摄入量incubationperiod/latencyperiod潜伏期IND=InvestigationalNewDrug临床研究新药INDA=investigationalnewdrugapplicationNDA前申报阶段indemnityinsurance赔偿保险IndependentDataMonitoring=IDM独立数据监察IndependentDataMonitoringCommittee=IDMC独立数据监察委员会independentethicscommittee=IEC独立伦理委员会indications适应症investigationalnewdrug=IND临床研究新药investigationalproduct试验药物investigator调研人员investigator'sbrochure=IB研究者手册Mmasked设盲meanabsorptiontime=MAT(药物在体内的)平均吸收时间meandisintegrationtime=MDIT(药物在体内的)平均崩解时间MeanDissolutionTime=MDT(药物在体内的)平均释放时间MeanResidenceTime=MRT(药物在体内的)平均滞留时间medicalgovernance医药治理Medicare老年医疗保险制度；联邦老年医保medicationguides(forpatients)用药指南MedicinesControlAgency=MCA英国药品监督局Misbranding错误标签;冒牌Miscoding编码错误missingvalue缺失值mixedeffectmodel混合效应模式MLD=minimallethaldose最小致死剂量MoA=MechanismofAction作用机制;作用机理monitor监查员monitoringplan监查计划monitoringreport监查报告MR=moderateresponse好转MRA=AgreementonMutualRecognition相互承认协定MTD=maximaltolerancedose最大耐受剂量multicentertrial多中心试验multi-drugresistance多药物抗药性multiplearmtrials多治疗组的试验mutualrecognitionprocedure(EU)相互承认程序OOS=Overallsurvival总生存率Pparallelgroupdesign平行组设计parameterestimation参数估计parametricrelease参数放行parametricstatistics参数统计方法pat